Patient Activation Through Counseling, Exercise and Mobilization

Herlev and Gentofte Hospital99 enrolled

Overview

PACE-Mobil-PBL is a prospective randomized controlled trial. The aim is to investigate the effect of a multimodal and exercise-based intervention among older patients with advanced pancreatic cancer, biliary tract cancer, or lung cancer during treatment with first-line palliative chemotherapy, immunotherapy or targeted therapy. The hypotheses: That the multimodal intervention will increase or maintain physical function levels and strength, reduce symptoms and side-effects, improve quality of life, reduce treatment-related complications and hospital admissions, and reduce risk of cancer cachexia and sarcopenia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Pancreas Cancer Biliary Tract Cancer Non Small Cell Lung Cancer Advanced Cancer

Interventions

Multimodal and exercise-based interventionBEHAVIORAL

The multimodal and exercise-based intervention is comprised of: 1. Supervised and group-based exercise two times a week (60 minutes per session). The program consists of warm-up, exercises for balance and flexibility, progressive resistance training, and stretching and relaxation. 2. Individualized activity program based on step counts (with activity tracker). Based on each participant's starting point, preferences and motivation, an individualized program will be composed. Evaluation and goal-setting will be conducted once weekly. 3. Nurse-led supportive and motivational counseling; each participant will be invited to two sessions of counseling (in week 1 + 6). Each session will be based on a holistic assessment of each participant's life situation. Advice and counseling will be provided based on identified problems and needs. 4. A nutritional supplement (protein bar or drink) will be served to participants immediately after the supervised exercise session.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria, participants must: * Be diagnosed with locally advanced or metastatic pancreatic cancer, OR locally advanced or metastatic biliary tract cancer, OR locally advanced or metastatic non-small cell lung cancer within 12 weeks. * Have unresectable cancer. * Be treated with first-line palliative chemotherapy, immunotherapy or targeted therapy at the Department of Oncology, Herlev and Gentofte Hospital. * Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Have the ability to speak and read Danish, and to provide a signed informed consent form. Exclusion Criteria, patients with: * Small-cell lung cancer. * Any physical condition that hinder the execution of physical exercise training. * Documented and uncontrolled brain metastases that hinder participation in an exercise-based trial, based on the referring oncologist's assessment. * Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial. * Unstable medical disease or history of serious or concurrent illness; any Medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted to congestive heart failure (NYHA class II-IV), unstable angina pectoris, implantable cardioverter defibrillator, or myocardial infarction within 6 months, based on the referring oncologist's assessment. In patients with bone metastases: \- A bone metastatic burden or location that poses a risk of injury in the performance of exercise training, as assessed by the referring oncologist.

Locations (1)

Herlev and Gentofte Hospital, Department of Oncology

Herlev, Denmark

Outcomes

Primary Outcomes

Lower body strength measured with the 30-second chair stand test

Number of stands a participant can complete in 30-seconds from a seated position with their arms crossed over the chest. The assessments will be conducted by a blinded physiotherapist

Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

Secondary Outcomes

Recruitment rate

Number of participants included from eligible patients

Time frame: Up to 2 years

Adherence to exercise sessions

Number of exercise sessions attended out of planned sessions

Time frame: Up to 12 weeks

Adherence to counseling sessions

Number of counseling sessions attended out of planned sessions

Time frame: Up to 12 weeks

Adverse events

Cases of exercise-related injuries or events, including, but not restricted to musculoskeletal-related events, falls, fall-related injuries, bleedings, or cardiovascular events.

Time frame: Up to 12 weeks

Physical performance measured with the 6-minute-walk-test

The distance (measured in meters) a participant is able to walk over a total of six minutes on a hard flat surface. The assessments will be conducted by a blinded physiotherapist

Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

Physical performance measured with the 6-meter Gait Speed Test

The assessments will be conducted by a blinded physiotherapist

Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

Upper-body strength measured with the Handgrip Strength Test

Handgrip strength will be measured using a hand-held Jamar dynamometer. The assessments will be conducted by a blinded physiotherapist

Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

Physical activity level

Step Counts (measured with Garmin Vivofit 3 activity tracker).

Time frame: Change measures (baseline, and 12 weeks).

Qualitative assessment of participants' experiences

Qualitative individual semi-structured interviews with participants from the intervention group

Time frame: After 12 weeks

Quality of life

Measured with the EORTC Quality of Life questionnaire (EORTC QLQ-C30)

Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

Symptoms of depression

Measured with the patient questionnaire 'Hospital Anxiety and Depression Scale' (HADS)

Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

Symptoms of anxiety

Measured with the 'Hospital Anxiety and Depression Scale' (HADS) patient questionnaire

Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

Symptom burden

Measured with the 'M.D. Anderson Symptom Inventory' patient questionnaire

Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

Number of participants with side-effects to oncological treatment assessed with the Common Toxicity Criteria for Adverse Events version 4

Data will be collected from medical charts

Time frame: Up to 6 months

Body weight

Weight will be measured using standard procedures (no shoes, light clothing) and will be reported in kilograms

Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

Body mass index

Reported in kg/m\^2

Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

Whole-body Lean body mass (LBM)

Measured with Bioimpedance and DXA scans

Time frame: Change measures (baseline, and 12 weeks)

Whole-body fat mass

Measured with Bioimpedance and DXA scans

Time frame: Change measures (baseline, and 12 weeks)

Whole-body bone mineral density

Measured with DXA scans

Time frame: Change measures (baseline, and 12 weeks)

Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40)

Data will be collected from medical charts

Time frame: Up to 6 months

Number of hospital admissions

Data will be collected from medical charts

Time frame: Up to 6 months

Causes of hospitalizations

Data will be collected from medical charts

Time frame: Up to 6 months

Length of hospitalizations (days)

Data will be collected from medical charts

Time frame: Up to 6 months

Survival

Data will be collected from medical charts

Time frame: Up to 2 years

Data from ClinicalTrials.gov

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